Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-17 are pending. Claims 1-17 are examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, 11, 15 recite a “method … comprising” in line 3 is ambiguous because following the term “comprising” are list of products but no steps for the methods which is confusing. Claims 2-10 are dependent on claim 1.
Claim 1 is confusing because the claim does not fulfill the preamble stated purpose of detecting an autophagy marker. Claims 2-10 are dependent on claim 1.
Claim 11 is confusing because the claim does not fulfill the preamble stated purpose of determining autophagic flux. Claims 12-14 are dependent on claim 11.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) is/are directed to an abstract idea of a mathematical equation and diagnostic steps The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The rationale for this determination is explained below and is based on USPTO’s 2014 Interim Guidance on Patent Subject Matter Eligibility, called ‘‘Interim Eligibility Guidance’’ (published in Federal Register /Vol. 79, No. 241 /Tuesday, December 16, 2014) and Interim Guidance published May 4, 2016 for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. 101 in view of recent decisions by the U.S. Supreme Court (Supreme Court). In Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo) 101 USPQ2d 1961, 1965-1966 (SC 2012) it was stated:
“Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972). And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it. (Emphasis added).
Still, as the Court has also made clear, to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words “apply it.”
Our conclusion rests upon an examination of the particular claims before us in light of the Court’s precedents. Those cases warn us against interpreting patent statutes in ways that make patent eligibility “depend simply on the draftsman’s art” without reference to the “principles underlying the prohibition against patents for [natural laws].” Flook, supra, at 593. They warn us against upholding patents that claim processes that too broadly preempt the use of a natural law. Morse, supra, at 112– 120; Benson, supra, at 71–72.
And they insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an “inventive concept,” sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself. Flook, supra, at 594; see also Bilski, supra, at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant post solution activity’” (quoting Diehr, supra, at 191–192)). (Emphasis added).
We find that the process claims at issue here do not satisfy these conditions. In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries. (Emphasis added)
1. Is the claimed invention directed to one of the four statutory categories, i.e. a process, machine, manufacture, or composition of matter?
2. Does the claim recite or involve judicial exception(s), i.e. abstract ideas, laws of nature/natural principles, natural phenomena, and natural products?
3. Does the claim as a whole recite something significantly different than the judicial exception(s)?
In the present case, the claims are directed to an abstract idea of a mathematical equation.
The answers to the first two questions of the claim eligibility chart is yes because the claim is to a method and the claim recites judicial exceptions of an abstract idea of calculation ratio using equation 1. These are abstract ideas which are performed by mathematical equation. The claims also recite the judicial exception of a diagnostic assay correlation of drug candidate to be cancer therapeutic agent of claims 15-17.
A claim that focuses on method of mental steps of natural assay must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the mental steps of natural principle itself. See Mayo, 101 USPQ2d at 1966. To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. The analysis turns on whether the claim has added enough to show a practical application. See id. at 1968. In other words, the claim cannot cover the natural principle itself such that it is effectively standing alone. A bare statement of a naturally occurring correlation, albeit a newly discovered natural correlation or very narrowly confined correlation, would fail this inquiry. See id. at 1965, 1971.
It is not necessary that every recited element or step integrate or relate to the natural principle and abstract idea as long as it is applied in some practical manner. However, there must be at least one additional element or step that applies, relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself.
Along with integration, the additional steps must be sufficient to ensure that the claim amounts to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to “apply it.” See id. at 1965, 1968. The additional elements or steps must narrow the scope of the claim such that others are not foreclosed from using the natural principle (a basic tool of scientific and technological work) for future innovation. Elements or steps that are well-understood, purely conventional, and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (field-of-use), would not be sufficiently specific. See id. at 1968.
In the present case, the claims encompass or are directed to an abstract idea of mathematical equations of using equation 1 to measure ratios. The claim recites judicial exceptions of an abstract idea of equation 1. These are abstract ideas which are performed by mathematical equations. The determining of drug candidate of claim 15 is a diagnostic correlation using the mathematical equation which is diagnostic application of the natural correlation properties.
The combination of steps recited in the claims taken as a whole, including those indicated above, are not sufficient to qualify as a patent-eligible practical application as the claims cover every substantial practical application of the mental steps without actual assay method elements. In particular, the step of generating and determining is recited at a high level of generality. Such a step is not sufficient to ensure that the claims amount to significantly more than the abstract correlation itself since every application of the correlation would require this. Furthermore, appending conventional steps, specified at a high level of generality, to an abstract principle is not sufficient to render a claim patent-eligible.
While the claim also recites a step of comparing the measured of predetermined theshhold, steps relating to the use of a cutoff value are well-understood and are routinely taken by those in the field to perform testing of a sample. Furthermore, as noted above the additional elements or steps must relate to the natural or abstract principle in a significant way to impose a meaningful limit on the claim scope. Moreover, steps of generating and determining analysis of generating adaptive immune profile and identifying alloreactive clones falling within the scope of the claims were also known and in use by others. Steps that amount to instructions that are well-understood, routine, conventional activity, previously engaged in by those in the field add nothing specific to the natural principle that would render it patent-eligible.
For all of these reasons, the claims do not include additional elements/steps or a combination of elements/steps that are sufficient to ensure that the claims amount to significantly more than a natural principle or abstract principle itself. When the claims are considered as a whole, the steps taken together amount to no more than recognizing the abstract principle or law of nature itself.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-8, 10-12, 14, is/are rejected under 35 U.S.C. 103 as being unpatentable over Noh (Autophagy, 2016) in view of Sim et al.(KR 10-2016-0128654.
Noh teach the method of LC3 localization with fluorescent labeling interaction with PEBP1 (page 2185). LC3 inherently has the LC3-I and LC3-II mixture in the reaction. Noh teaches the Chloroquine inhibitor (page 2192). Noh does not teach the method using localized plasmon resonance.
Sim teach the method detecting biomarkers with gold nanoparticles nanorods and antibody measuring with localized surface plasmon resonance (page 6). Sim teach the measuring the Rayleigh scattering spectrum obtaining a maximum wavelength wavelength shift (page 6, 9). Sim teach the range of 106 fM (page 19).
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the teaching of Sim of using localized surface plasmon resonance to Noh teaching of autophagy status in cancer cells with LC3 markers. One of ordinary skill in the art would be motivated to combine the teaching because the localized surface plasmon resonance allows better reproducibility and factory automation according to Sim (page 4).
The equation is considered mental and abstract steps which the method can think about.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible time.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D PAK/Primary Examiner, Art Unit 1674